510(k) K210747 ยท QIH Automated Radiological Image Processing Software
Caption Interpretation Automated Ejection Fraction Software
| Applicant | Caption Health, Brisbane CA, US |
| Decision | Substantially Equivalent, Jan 19, 2022 |
| Received | Mar 12, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210747
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.